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United Therapeutics Corporation, a biotechnology company, focuses on the development and commercialization of products that address the unmet medical needs of patients with chronic and life-threatening conditions.
Products and Product Candidates
Prostacyclin Analogues: Prostacyclin analogues are stable synthetic forms of prostacyclin, an important molecule produced by the body that has powerful effects on blood vessel health and function. The company’s main product is Remodulin (treprostinil) Injection (Remodulin), which is administered subcutaneously (under the skin) or intravenously (in the vein) for the treatment of pulmonary arterial hypertension (PAH). The United States Food and Drug Administration (FDA) approved Remodulin in 2002 for subcutaneous administration. Subsequently, the FDA broadened its approval of Remodulin for intravenous use and for the treatment of patients who require transition from Flolan (epoprostenol). Outside the United States, Remodulin is approved in 37 countries, most of which have approved both routes of administration. In December 2013, the FDA approved Orenitram (treprostinil) Extended-Release Tablets (Orenitram).
The company is also conducting pre-clinical studies of a self-injectable form of treprostinil, which the company refers to as TransCon treprostinil. The company’s wholly-owned subsidiary Lung Biotechnology Inc., formerly known as Lung LLC, is in the process of developing another prostacyclin analogue licensed from Toray Industries, Inc. (Toray) called beraprost, for treatment of PAH both as an oral tablet known as 314d and as an extended release injection the company refers to as TransCon beraprost.
Phosphodiesterase Type 5 (PDE-5) Inhibitor: The company’s PDE-5 inhibitor product is Adcirca (tadalafil) tablets (Adcirca), a once-daily oral therapy for the treatment of PAH. The company acquired exclusive U.S. commercialization rights to Adcirca from Eli Lilly and Company (Lilly) in 2008. In 2009, the FDA approved Adcirca for the treatment of PAH.
Monoclonal Antibody (MAb): MAbs act by targeting tumor-associated antigens on cancer cells to activate a patient's immune system against the cancer cells. The company is in the process of developing the antibody Ch14.18 MAb for the treatment of neuroblastoma, under an agreement with the National Cancer Institute (NCI) of the United States National Institutes of Health (NIH).
Glycobiology Antiviral Agents: Glycobiology antiviral agents are a novel class of small, sugar-like molecules that have shown pre-clinical indications of efficacy against a range of viruses. In 2011, the company was awarded a contract from the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH for studies directed at the development of a broad spectrum antiviral drug based on its glycobiology antiviral platform.
Cell-Based Therapy: In 2011, the company entered into a license agreement with Pluristem Ltd. (Pluristem) to develop and commercialize its cell-based product known as PLacental eXpanded (PLX) cells for the treatment of PAH. The company commenced a phase I clinical study in Australia in 2013.
Lung Transplantation: The only reported cure for PAH is a lung transplant. Using the xenotransplantation technology, the company is in the early pre-clinical stage of developing engineered lungs and lung tissue for transplant into patients suffering from PAH and other lung diseases. The company is also developing technologies to increase the supply of donor lungs through collaborations with two ex-vivo lung perfusion companies.
Sales and Marketing
The company has divided its domestic sales force into two teams. One team sells Remodulin and Tyvaso and will sell Orenitram, while the other team sells Adcirca. For Remodulin and Tyvaso, the activities of its sales and marketing teams are supplemented in the United States by specialty pharmaceutical distributors. Outside of the United States, the company has entered into distribution agreements for Remodulin covering those territories where Remodulin is approved.
The company has entered into separate, non-exclusive distribution agreements with Accredo Health Group, Inc. (Acc

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